510(k) K033616

TRAPMATIC SYSTEM SET by H.S Hospital Service S.P.A — Product Code KNW

K033616 is an FDA 510(k) premarket notification submitted by H.S Hospital Service S.P.A for the device "TRAPMATIC SYSTEM SET". The FDA issued a decision of Substantially Equivalent on Mar 1, 2004. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. H.S Hospital Service S.P.A has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 1, 2004
Date Received
Nov 17, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type